QA Compliance Specialist (Medical Devices)

Medical Components, Inc.; Harleysville (PA); Presencial; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

Medical Components, Inc. is seeking a Quality Assurance Specialist to support our QMS and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and MDSAP.

The role acts as the delegated QA authority for DHR review and product release, while supporting CAPA, Change Control, validation, and internal audits. The ideal candidate will be detail-oriented, with 2–5 years of QA experience in medical device manufacturing or a regulated field, and strong analytical and communication skills to thrive in a

Formación

• Bachelor's degree in Engineering, Life Sciences, or related field.

Responsabilidades

• Review DHR and supporting documentation to ensure compliance with product specifications and quality requirements.

Conocimientos

QA

Regulatory knowledge

DHR review

Analytical thinking

Communication

Educación

Bachelor's degree in Engineering or Life Sciences

Herramientas

Microsoft Office

eQMS

Descripción del empleo

Medical Components, Inc. is seeking a Quality Assurance Specialist to support our QMS and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and MDSAP.

The role acts as the delegated QA authority for DHR review and product release, while supporting CAPA, Change Control, validation, and internal audits. The ideal candidate will be detail-oriented, with 2–5 years of QA experience in medical device manufacturing or a regulated field, and strong analytical and communication skills to thrive in a